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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clamp, umbilical
510(k) Number K871075
Device Name SCMT UMBILICAL CLAMP
Applicant
SALT CREEK MEDICAL TECHNOLOGIES
5500 ARAPAHO PASS
PINCKNEY,  MI  48169
Applicant Contact HOWARD MEADE
Correspondent
SALT CREEK MEDICAL TECHNOLOGIES
5500 ARAPAHO PASS
PINCKNEY,  MI  48169
Correspondent Contact HOWARD MEADE
Regulation Number884.4530
Classification Product Code
HFW  
Date Received03/18/1987
Decision Date 03/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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